Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery (IPLA)

January 14, 2019 updated by: Göteborg University

Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study.

The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden, SE41385
        • Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Patients with widespread malignant intra-abdominal ovary cancer stadium III-IV and are operated by extensive resection of intra-abdominal viscera as well as the parietal peritoneum (cytoreductive surgery, CRS)

Exclusion Criteria:

  • Body mass index > 35
  • American Society of Anesthesiologists classification > 3
  • Renal dysfunction
  • Allergic to acetylsalicylic acid
  • Unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group R
Ropivacaine is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Ropivacaine would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Ropivacaine (1mg/mL) would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.
Drug: Ropivacaine
Active Group
Other Names:
  • Narop
Placebo Comparator: Group P
Saline is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Saline would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.
Drug: Saline
Placebo Comparator
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Markers
Time Frame: 0-48 hours postoperatively
Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1β, IL-1rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, zBasic FGF (Fibroblast Growth Factor), Eotaxin, G-CSF (granulocyte colony stimulating factor), GM-CSF granulocyte macrophage colony stimulating factor), IFN-γ (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1α (macrophage inflammatory protein), MIP-1β, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor), VEGF (vascular endothelial growth factor)
0-48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Morphine consumption
Time Frame: 0-48 hours postoperatively
Total amount of Morphine consumed during the first 48 hours after surgery
0-48 hours postoperatively
Pain Intensity
Time Frame: 0-48 hours postoperatively
Pain Intensity is measured with Numeric Rating Score 0-10
0-48 hours postoperatively
Cognitive Function
Time Frame: 0-1 month postoperatively
Patients will complete the following neurophysiological tests upon entering the study and within one month after surgery: Verbal Learning Test (VLT), Concept Shifting Test (CST), Letter-Digit Coding, Verbal Learning Test - Delayed Recall (VLT-D)
0-1 month postoperatively
Progression-free Survival
Time Frame: 0-3 years postoperatively
Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.
0-3 years postoperatively
Postoperative Morbidity/Complications
Time Frame: 0-30 days postoperatively

Measuring the numbers of Postoperative Morbidity/Complications within one month after surgery:

Morbidity:

  • Local infections
  • Urinary infection (urine culture)
  • Pneumonia (X-ray, C-reactive protein, Fever)
  • Sepsis (Fever, Leucocyte count in blood, Heart Rate, Respiratory Rate)
  • Pleural fluid (X-ray verified)
  • Deep Vein Thrombosis (D-dimer, ultrasound verified)
  • Pulmonary embolism (Computed Tomography/ Scint-X)
  • Acute Myocardial Infarction (Electrocardiography, Troponin I)
  • Atrial fibrillation or serious arrhythmia during the first 48 hours after surgery (Electrocardiography)
  • Respiratory failure (prolonged mechanical ventilation)
  • Renal failure (Serum Creatinine, Diuresis, AKIN criteria)
  • Inotropic needs > 12 hours after surgery

Surgical Complications:

  • Intraabdominal bleeding
  • Leakage from anastomosis
  • Abdominal abscess
  • Paralytic ileus
  • Pancreatic leakage (requiring drainage)
0-30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Sven-Egron Thorn, MD PhD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Anil Gupta, MD PhD, Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
  • Study Chair: Sven-Erik Ricksten, MD PhD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPLA-CRS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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